Method of repairing soft tissue using sizing templates

ABSTRACT

Surgical instruments for use in sizing tissue defects and selecting an appropriate implant for the defect include sizing templates. The sizing templates are sized and shaped to correspond to the size and shape of the implants. The sizing templates may be retractable into a tube for use in arthroscopic surgery. The retractable sizing templates are resilient to allow them to be retracted into a small diameter tube, and to expand on release from the tube to the desired size and shape. The method of using the instrument set is also described.

This application claims the benefit of U.S. Provisional Application No.60/623,366 filed on Oct. 29, 2004, by Anthony D. Zannis, Danny E.McAdams, Brian A. Magee, Herbert E. Schwartz and Andrew M. Jacobsentitled “Implant System and Method with Sizing Templates,” which isincorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The present invention relates to implants and surgical instruments andmore particularly to surgical instrument sets that can be used tointraoperatively select the most appropriate implant for repair of atissue defect.

BACKGROUND OF THE INVENTION

Various types of MIS are being performed by surgeons, includinglaparascopy, endoscopy and arthroscopy surgery. In arthroscopy, smallincisions are made at the affected joint to form portals for theinsertion of instruments, including a small lens and lighting system (anarthroscope). The arthroscope is connected to a viewing device, such asa television camera to allow the surgeon to see the interior of thejoint. Other instruments are inserted through other portals to perform avariety of tasks. For example, the surgical instrument may include animplement for manipulating native tissue (for example, tissue grasping,tissue cutting, bone abrading), or an implement for introducing andimplanting a therapeutic device.

Typical surgical instruments used in arthroscopic procedures includerongeurs, such as the Kerrison rongeur, punch forceps, basket forceps,suction punches and cup curet, for example. Examples of arthroscopicinstruments are described and illustrated in O'Connor's Textbook ofArthroscopic Surgery, 2^(nd) ed., 1992, Chapter 19.

In many surgical settings, it is often necessary for the surgeon to makemeasurements between two points. Due to the confined spaces ofarthroscopic surgery, measuring such distances is often quite difficult,particularly when the measurement needed is larger than the size of theincision or transverse to the direction of the incision. Arthroscopicknee surgery provides many such situations. For example, it may behelpful if a surgeon could measure the size of a defect in the meniscusof a knee, to aid in choosing the appropriate method to repair thedefect.

An arthroscopic measuring device is disclosed in U.S. Pat. No.6,427,351B1, which is incorporated by reference herein in its entirety.The device disclosed in that patent provides a handle and an extension.The extension has a distal tip for intraoperative insertion into thebody through an incision. Two wires extend from a block in the handlethrough passageways in two separate tubes that comprise the extension.The block is connected to an actuator element. The actuator elementsdisclosed can be moved back and forth in a direction parallel to thelongitudinal axis of the handle to move the wires out of an into thetubes. At their distal ends, the tubes diverge at a fixed angle so thatthe distance between the ends of the wires increases as the wires arepushed further outward and decreases as the wires are pulled back intothe handle. Calibrations on the handle correspond with the distancebetween the ends of the wires so that the surgeon can determine one ormore of the dimensions of a defect in the bone or cartilage.

Although the arthroscopic measuring device disclosed in U.S. Pat. No.6,427,351B1 provides a useful surgical tool, operation of the actuatingmechanism disclosed can be difficult for the surgeon, particularly dueto friction as the wires are pushed through the divergent tube endings.In addition, use of that device may require that the surgeon use bothhands to hold the handle and move the actuating mechanism. Finally, useof that device may not allow for repeatable measurements of the tissueand changes in the tissue over time.

Determining the size and location of a defect at a tissue site, such asthe meniscus of the knee joint, can be useful in several arthroscopicprocedures. Common surgical procedures for treating meniscal damageinclude tear repairs and menisectomies. A tear repair is most commonlyperformed when the tear is a clean longitudinal vertical lesion in thevascular red zone of the meniscus. The basic strategy is to stabilizethe tear by limiting or eliminating radial separation of the faces ofthe tear when the meniscus is load bearing. Many devices and surgicalprocedures exist for repairing meniscal tears by approximating the facesof the meniscus at the tear. Examples of such devices and procedures aredisclosed in the following U.S. Pat. Nos.: 6,319,271; 6,306,159;6,306,156; 6,293,961; 6,156,044; 6,152,935; 6,056,778; 5,993,475;5,980,524; 5,702,462; 5,569,252; 5,374,268; 5,320,633; and 4,873,976.

Menisectomies involve the surgical removal of part of the meniscus. Suchprocedures have generally been performed in cases of radial tears,horizontal tears, vertical longitudinal tears outside the vascular zone,complex tears, or defibrillation. Although menisectomies provideimmediate relief to the patient, in the long term the absence of part ofthe meniscus can cause cartilage wear on the condylar surface,eventually leading to arthritic conditions in the joint.

A variety of orthopaedic implants are available for treating damagedsoft tissue. Orthopaedic implants for treatment of damaged menisci aredisclosed in the following U.S. Pat. Nos. 6,042,610; 5,735,903;5,681,353; 5,306,311; 5,108,438; 5,007,934; and 4,880,429.

The sizes and shapes of meniscal defects, including the gaps leftfollowing menisectomies, can vary from patient to patient. Typically,orthopaedic implants for treating such defects would be provided in avariety of sizes. To select the appropriate implant for a patient, thesurgeon would typically use an arthroscopic probe to approximate thesize of the defect. However, due to a large margin of error in suchapproximations, it is desirable to provide surgeons with a more accurateway to select the most appropriate implant for a particular defect.

SUMMARY OF THE INVENTION

The present invention provides an instrument set and a surgicaltechnique for sizing a tissue defect so that the most appropriate sizeof implant is selected for the defect.

In one aspect, the present invention provides a surgical sizinginstrument comprising a hollow tube and elongated sizing template. Thehollow tube has a proximal end and a distal end. The elongated sizingtemplate extends through the hollow tube, and includes proximal end, adistal end, an intermediate portion between the proximal end and distalend, a first resilient segment adjacent to the intermediate portion, anda second resilient segment adjacent to the first resilient segment andpositioned between the first resilient segment and the distal end of theelongated sizing template. The elongated sizing template is reciprocablein the hollow tube between an extended position and a retractedposition. The first resilient segment and second resilient segment arereceived within the hollow tube when the elongated sizing template is inthe retracted position and exposed outside of the hollow tube when theelongate sizing template is in the extended position. The firstresilient segment and second resilient segment have a first relativeorientation when the elongated sizing template is in the extendedposition and a second relative orientation when the elongated sizingtemplate is in the retracted position. The first relative orientationbeing different from the second relative orientation.

In another aspect, the present invention provides a surgical sizinginstrument set comprising first and second surgical sizing instruments.Both surgical sizing instruments include a hollow tube and an elongatedsizing template. The hollow tubes have a proximal end and a distal end.Each of the elongated sizing templates extends through one hollow tubeEach elongate sizing template has a proximal end, a distal end, anintermediate portion between the proximal end and distal end, a firstresilient segment adjacent to the intermediate portion, and a secondresilient segment adjacent to the first resilient segment and positionedbetween the first resilient segment and the distal end of the elongatedsizing template. The elongated sizing templates are reciprocable in thehollow tubes between extended positions and retracted positions. In eachinstrument, the first resilient segment and second resilient segmenthave a first angular relationship when the elongated sizing template isin the extended position and a second angular relationship when theelongated sizing template is in the retracted position. In each, thefirst angular relationship is different from the second angularrelationship.

In another aspect, the present invention provides a surgical instrumenthaving a proximal end and a distal end. The instrument comprises ahandle at the proximal end and a tube extending distally from thehandle. The tube defines a channel. The instrument also comprises afirst gear, a second gear and an elongated member. The first gear isrotatably mounted to the handle, and has a plurality of grooved teeth.The second gear is rotatably mounted to the handle, and has a pluralityof grooved teeth intermeshed with the grooved teeth of the first gear.The grooves of the intermeshed teeth of the first gear and second geardefine a passageway aligned with the channel of the tube. The elongatedmember extends through the passageway and into the channel of the tube.The elongated member is movable in a proximal direction by rotating thefirst gear in one direction and movable in the distal direction byrotating the first gear in the opposite direction.

In another aspect, the present invention provides a surgical implantsystem. The system comprises first and second implants and first andsecond sizing instruments. The first implant has a width and a lengthand the second implant has a width and a length. At least one of thewidth and length of the second implant is larger than the correspondingdimension of the first implant. The first surgical sizing instrumentincludes a hollow tube and an elongated sizing template. The hollow tubehas a proximal end and a distal end. The elongated sizing templateextends through the hollow tube, and has a proximal end, a distal end,an intermediate portion between the proximal end and distal end, a firstresilient segment adjacent to the intermediate portion, a secondresilient segment adjacent to the first resilient segment and positionedbetween the first resilient segment and the distal end of the elongatedsizing template. The elongated sizing template is reciprocable in thehollow tube between an extended position and a retracted position. Thefirst resilient segment has a length corresponding with the width of thefirst implant and the second resilient segment has a lengthcorresponding with the length of the first implant. The first resilientsegment and second resilient segment have a first angular relationshipwhen the elongated sizing template is in the extended position and asecond angular relationship when the elongated sizing template is in theretracted position. The first angular relationship is different from thesecond angular relationship. The second surgical sizing instrumentincludes a hollow tube and an elongated sizing template. The hollow tubehas a proximal end and a distal end. The an elongated sizing templateextends through the hollow tube and has a proximal end, a distal end, anintermediate portion between the proximal end and distal end, a firstresilient segment adjacent to the intermediate portion, a secondresilient segment adjacent to the first resilient segment and positionedbetween the first resilient segment and the distal end of the elongatedsizing template. The elongated sizing template of the second sizinginstrument is reciprocable in the hollow tube between an extendedposition and a retracted position. The first resilient segment of theelongated sizing template of the second sizing instrument has a lengthcorresponding with the width of the second implant and the secondresilient segment has a length corresponding with the length of thesecond implant. The first resilient segment and second resilient segmentof the second sizing instrument have a first angular relationship whenthe elongated sizing template is in the extended position and a secondangular relationship when the elongated sizing template is in theretracted position, the first angular relationship being different fromthe second angular relationship.

In another aspect, the present invention provides a method of repairingsoft tissue. Soft tissue is removed to create a defect having a firstside having a length and orientation and a second non-parallel sidehaving a length and orientation. First and second implants are provided.The first implant includes a first side having a length and orientationand a second non-parallel side having a length and orientation. Thesecond implant also has a first side having a length and orientation anda second non-parallel side having a length and orientation. First andsecond sizing templates are provided. The first sizing template includesa first side having a length and orientation corresponding to the lengthand orientation of the first side of the first implant and a second sidehaving a length and orientation corresponding to the length andorientation of the second side of the first implant. The second sizingtemplate includes a first side having a length and orientationcorresponding to the length and orientation of the first side of thesecond implant and a second side having a length and orientationcorresponding to the length and orientation of the second side of thesecond implant. One of the sizing templates is introduced to the area ofthe defect and positioned with its first side at the first side of thedefect and with its second side at the second side of the defect. Thesurgeon can then determine whether the introduced sizing template fitsthe defect. The sizing template is removed and one of the implants isintroduced to the area of the defect and positioned in the defect.

Additional features of the present invention will become apparent tothose skilled in the art upon consideration of the following detaileddescription of preferred embodiments exemplifying the best mode ofcarrying out the invention as presently perceived.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of a set of surgical instruments with sizingtemplates in an extended position;

FIG. 2 is a top plan view of the surgical instruments of FIG. 1 withsizing templates in a retracted position;

FIG. 3 is a bottom plan view of the tube and shoulder assembly of someof the instruments of FIGS. 1-2;

FIG. 4 is a side elevation of the tube and shoulder assembly of FIG. 3;

FIG. 5 is a cross-section of the tube and shoulder assembly of FIGS.3-4, taken along line 5-5 of FIG. 4;

FIG. 6 is a bottom plan view of the tube and shoulder assembly of otherinstruments in the set of FIGS. 1-2;

FIG. 7 is a side elevation of the tube and shoulder assembly of FIG. 6;

FIG. 8 is a cross-section of the tube and shoulder assembly of FIGS.6-7, taken along line 8-8 of FIG. 7;

FIG. 9 is an enlarged top plan view of the distal end portion of thelarge sizing template of the instrument set of FIGS. 1-2;

FIG. 10 is an enlarged top plan view of a large size meniscal implantthat may be included as part of the system of the present invention;

FIG. 11 is an enlarged top plan view of the distal end portion of themedium sizing template of the instrument set of FIGS. 1-2;

FIG. 12 is an enlarged top plan view of a medium size meniscal implantthat may be included as part of the system of the present invention;

FIG. 13 is an enlarged top plan view of the distal end portion of thesmall sizing template of the instrument set of FIGS. 1-2;

FIG. 14 is an enlarged top plan view of a small size meniscal implantthat may be included as part of the system of the present invention;

FIG. 15 is an end view of one of the meniscal implants of FIGS. 10, 12and 14;

FIG. 16 is a plan view of the small sizing template of the instrumentset of FIGS. 1-2;

FIG. 17 is a plan view of the medium sizing template of the instrumentset of FIGS. 1-2;

FIG. 18 is a plan view of the large sizing template of the instrumentset of FIGS. 1-2;

FIG. 19 is a cross-section of the distal end of the straight tube of oneof the instruments of FIGS. 1-2, shown with the large sizing template ina retracted position;

FIG. 20 is a cross-section of the distal end of the straight tube ofanother of the instruments of FIGS. 1-2, shown with the medium sizingtemplate in a retracted position;

FIG. 21 is a cross-section of the distal end of the straight tube ofanother of the instruments of FIGS. 1-2, shown with the small sizingtemplate in a retracted position;

FIG. 22 is a cross-section of the distal end of the angled tube of oneof the another of the instruments, shown with the large sizing templatein a retracted position;

FIG. 23 is a cross-section of the distal end of the angled tube of oneof the another of the instruments, shown with the medium sizing templatein a retracted position;

FIG. 24 a cross-section of the distal end of the angled tube of one ofthe another of the instruments, shown with the small sizing template ina retracted position;

FIG. 25 is a longitudinal cross-section of the handle assembly of one ofthe instruments of FIGS. 1-2, taken along line 25-25 of FIG. 2;

FIG. 26 is a transverse cross-section of the handle assembly of one ofthe instruments of FIGS. 1-2, taken along line 26-26 of FIG. 2;

FIG. 27 is an enlarged view of a portion of FIG. 26, showing a sizingtemplate in a passageway defined by grooves in the intermeshing teeth oftwo gears;

FIG. 28 is a diagrammatic perspective view of a meniscus, illustratinguse of one of the instruments of the present invention to size a defectin the meniscus;

FIG. 29 is a perspective view of an alternative embodiment of aninstrument useful in sizing a defect; and

FIG. 30 is a perspective view of another alternative embodiment of aninstrument useful in sizing a defect.

DETAILED DESCRIPTION

Surgical instruments embodying the principles of the present inventionare illustrated in the accompanying drawings. FIG. 1 illustrates asurgical instrument set 10 comprising a plurality of individualinstruments 12A, 12B, 12C, 12D, 12E, 12F that can be used to determinethe appropriate size of implant to be used in treating a tissue defect,such as a meniscal defect. As used herein, “defect” is intended toinclude both tissue tears and gaps in tissue left after part of thetissue has been removed, such as through a menisectomy. Although theillustrated instrument set 10 includes six individual instruments, itshould be understood that the principles of the present invention areapplicable to instrument sets having fewer or more than six instruments,as well as to individual instruments; the present invention should notbe considered to be limited to any particular number of instrumentsunless expressly called for in the claims.

As shown in FIG. 1, each of the illustrated instruments 12A, 12B, 12C,12D, 12E, 12F of the set 10 has a proximal end 11A, 11B, 11C, 11D, 11E,11F and an opposite distal end. As used herein, “proximal” refers to theend or portion nearer to the surgeon, and “distal” refers to the end orportion further from the surgeon.

It should be understood that the illustrated instrument set is designedfor use in sizing meniscal implants; variations may be made in theillustrated instrument set for application to use at other tissue sitesin the patient's body.

As shown in FIG. 1, each illustrated instrument 12A, 12B, 12C, 12D, 12E,12F in the set 10 includes an elongated hollow tube 14A, 14B, 14C, 14D,14E, 14F and an elongated sizing template 16A, 16B, 16C, 16D, 16E, 16F.Each tube 14A, 14B, 14C, 14D, 14E, 14F has a distal end 18A, 18B, 18C,18D, 18E, 18F and a proximal end (shown at 32D and 32A in FIGS. 5 and8). Each sizing template 16A, 16B, 16C, 16D, 16E, 16F has a proximal end19A, 19B, 1 9C, 19D, 19E, 19F, a straight intermediate portion 20A, 20B,20C, 20D, 20E, 20F and a distal end 21A, 21B, 21C, 21D, 21D, 21E, 21F.As shown in FIG. 1, each illustrated instrument includes a handleassembly 26A, 26B, 26C, 26D, 26E, 26F. The handle assemblies receive theproximal ends of the hollow tubes 14A, 14B, 14C, 14D, 14E, 14F, asdescribed in more detail below.

The illustrated instrument set 10 includes instruments with threedifferent styles of elongate tubes. Three of the illustrated instruments12A, 12B, 12C have tubes 14A, 14B, 14C that are straight along theirentire length from the proximal to distal end. Three of the illustratedinstruments 12D, 12E, 12F have tubes 14D, 14E, 14F that are straight forthe majority of their lengths but that are curved near the distal ends18D, 18E, 18F. In three of the instruments 12D, 12E, 12F the curvedportions of the tubes curve to the side; the instruments can curve tothe left or to the right (in a top plan view) by adjusting the tube 14D,14E, 14F. With these different tube configurations available in theinstrument set, the surgeon can select the most appropriate instrumentfor the particular defect site and surgical approach. It should beunderstood that the illustrated variations in tube shapes are providedas examples only; the present invention is not limited to any particularshape of tube or to any particular number of choices available to thesurgeon unless expressly called for in the claims.

FIGS. 3-8 illustrate two of the hollow tubes 14A, 14D of the instrumentsof FIGS. 1-2. For simplicity, only these illustrated tubes 14A, 14D aredescribed below. However, it should be understood that the followingdescription applies to all of the hollow tubes 14A, 14B, 14C, 14D, 14E,14F unless an express distinction is made for a particular type of tube.

As shown in FIGS. 5 and 8, the hollow tubes 14A, 14D define longitudinalchannels 30A, 30D. The channels 30A, 30D are open at the proximal end32A, 32D and distal end 18A, 18D of the tubes 14A, 14D. The proximalends 32A, 32D of the tubes 14A, 14D are received in shoulder components34A, 34D. As shown in FIGS. 5 and 8, the shoulder components 34A, 34Dhave a distal channel 36A, 36D and a reduced diameter proximal channel38A, 38D. All of the channels 30A, 30D, 36A, 36D, 38A, 38D are co-axial.

The hollow tubes 14A, 14D may be made of any suitable medical gradematerial for instruments, such as 304 stainless steel tubing. In theillustrated embodiments, the straight hollow tube 14A is 4.25 incheslong, has an outer diameter of 0.148 inches and an inner diameter of0.118 inches. In the curved hollow tube 14D, the curved distal portiondefines a 45° angle with the straight portion of the tube; the proximalstraight portion has a length of about 3.525 inches and the tube has anoverall length of 4.160 inches. The shoulders 34A, 34D may be made ofany suitable medical grade material for instruments, such as 17-4 PH TYP630 stainless steel, for example. The shoulders 34A, 34D and tubes 14A,14D may be welded together or connected in any other manner to createthe sub-assemblies illustrated in FIGS. 3-8. The proximal portions ofthe shoulder components 34A, 34D have diametrically-opposed dimples 40A,40D for mounting the tube sub-assemblies to the handle assembly 26A,26D, as described in more detail below.

The sizing templates 16A, 16B, 16C, 16D, 16E, 16F are reciprocablewithin the tubes 14A, 14B, 14C, 14D, 14E, 14F, within the shouldercomponents 34A, 34B, 34C, 34D, 34E, 34F and within the handle assemblies26A, 26B, 26C, 26D, 26E, 26F in a proximal-distal direction and can bemoved between extended positions and retracted positions. In FIG. 1, theinstruments 12A, 12B, 12C, 12D, 12E, 12F of the set 10 are illustratedwith the sizing templates 16A, 16B, 16C, 16D, 16E, 16F in their extendedpositions, wherein parts of the sizing templates are exposed beyond thedistal ends 18A, 18B, 18C, 18D, 18E, 18F of the tubes 14A, 14B, 14C,14D, 14E, 14F. The instrument set 10 of FIG. 1 is shown in FIG. 2 withthe sizing templates 16A, 16B, 16C, 16D, 16E, 16F in the retractedposition. In the retracted position, the distal end 21A, 21B, 21C, 21D,21E, 21F of each sizing template is retracted into the correspondingtube of that instrument. When the sizing templates 16A, 16B, 16C, 16D,16E, 16F are fully retracted, the distal ends of the instruments are atthe distal ends 18A, 18B, 18C, 18D, 18E, 18F of the tubes; when thesizing templates 16A, 16B, 16C, 16D, 16E, 16F are fully extended, thedistal ends of the instruments are at the distal ends 21A, 21B, 21C,21D, 21E, 21F of the sizing templates.

In the illustrated instrument set 10, three different sizes of sizingtemplates are provided for each tube style. Generally, at least oneinstrument is included in the kit to correspond with each size ofimplant in the system. For example, if the implant system includes threesizes of meniscal implants, small, medium and large, the instrument setwould include at least three sizing templates, small, medium and large.

Three sizes of meniscal implants are illustrated in FIGS. 10, 12 and 14.FIG. 10 illustrates a large size meniscal implant 50 and FIG. 9illustrates an example of the distal end 21A, 21D of a sizing template16A, 16D that corresponds with this large sized implant 50. FIG. 12illustrates a medium size meniscal implant 52 and FIG. 11 illustrates anexample of the distal end 21B, 21E of a sizing template 16B, 16E thatcorresponds with this medium size implant 52. FIG. 14 illustrates asmall size meniscal implant 53 and FIG. 13 illustrates an example of thedistal end 21C. 21F of a sizing template 16C, 16F that corresponds withthis small size implant 53. All three implants 50, 52, 53 have a similarshape in end view; a representative end view of the large implant 50 isillustrated in FIG. 15, showing the wedge-shape of the implant.

Each of the three illustrated meniscal implants 50, 52, 53 includes acover 55 and a wedge 57. As illustrated, the top portion of the cover 55extends over and beyond the sides or edges of the wedge 55 to providefixation areas 59, 61. The fixation areas 59, 61 may be used to sutureor otherwise fix the implant 50, 52, 53 to native tissue or bone, andthe wedge 55 generally fills the gap in the native meniscal tissue leftafter a partial meniscetomy. It is anticipated that surgeons will trimthe fixation areas 59, 61 intra-operatively to suit the needs of theindividual patient. The cover 55 may comprise a laminate of sheets oftissue repair material, and the wedge 57 may also comprise tissue repairmaterial, as disclosed in U.S. patent application Ser. No. 10/747,349,entitled “Implantable Tissue Repair Device and Method,” filed on Dec.29, 2003 by Malaviya et al., which is incorporated by reference hereinin its entirety. The therapeutic implant, method of making the implant,and method of repairing cartilage using the implant may include theteachings of the following U.S. patent applications, the completedisclosures of which are incorporated by reference herein: Ser. No.10/172,347 entitled “Hybrid Biologic-Synthetic Bioabsorbable Scaffolds”(U.S. Patent Publication No. 20030023316A1); Ser. No. 10/195,334entitled “Cartilage Repair and Regeneration Scaffolds and Method” (U.S.Patent Publication No. 20030033021A1); Ser. No. 10/195,341 entitled“Hybrid Biologic/Synthetic Porous Extracellular Matrix Scaffolds” (U.S.Patent Publication No. 20030021827A1); Ser. No. 10/195,344 entitled“Unitary Surgical Device and Method” (U.S. Patent Publication No.20030078617A1); Ser. No. 10/195,354 entitled “Porous ExtracellularMatrix Scaffold and Method” (U.S. Patent Publication No. 20030044444A1);Ser. No. 10/195,606 entitled “Cartilage Repair and Regeneration Deviceand Method” (U.S. Patent Publication No. 20030033022A1); Ser. No.10/195,633 entitled “Porous Delivery Scaffold and Method” (U.S. PatentPublication No. 2003-0049299A1; Attorney Docket No. 265280-71207,DEP-762); Ser. No. 10/195,719 entitled “Devices from Naturally OccurringBiologically Derived Materials” (U.S. Patent Publication No.20030032961A1); and Ser. No. 10/195,794 entitled “Meniscus RegenerationDevice and Method” (U.S. Patent Publication No. 20030036797A1; AttorneyDocket No. 265280-71141, DEP-745). It should be understood that theparticular implants, features of the implants, methods of making theimplants and methods of repairing cartilage are provided as examplesonly; the present invention is not limited to the illustrated implantsor to meniscal implants or to any particular method of making or usingimplants unless expressly called for in the claims.

As shown in FIGS. 10, 12 and 14-15, each of the illustrated implants 50,52, 53 has an overall length L₁, L₂, L₅ between the side edges of thecover 55, an overall width W₁, W₂, W₅ between the front and back edgesof the cover 55, and a maximum thickness T₁ between the top and bottomsurfaces of the cover 55. The wedge portion 57 of each implant 50, 52,53 has a length L₃, L₄, L₆ between the side edges of the wedge 57, awidth W₃, W₄, W₆ between the front and back edges of the wedge 57, and amaximum thickness T₂ between the top and bottom surfaces of the wedge57. In the illustrated embodiments: L₁ is about 1.30 inches; L₂ is about1.11 inches; L₅ is about 0.91 inches; L₃ is about 0.98 inches; L₄ isabout 0.79 inches; L₆ is about 0.59 inches; W₁ is about 0.87 inches; W₂is about 0.87 inches; W₅ is about 0.87 inches; W₃, W₄, W₆ are about 0.47inches; T₁ is about 0.31 inches; and T₂ is about 0.22 inches. It shouldbe understood that these dimensions are provided as examples only; thepresent invention is not limited to any particular dimension unlessexpressly called for in the claims.

As shown in FIGS. 9-11, the sizing templates 16A, 16B, 16C, 16D, 16E,16F corresponding with each implant size have first sides or segments54A, 54B, 54C, 54D, 54E, 54F adjacent to the intermediate portions 20A,20B, 20C, 20D, 20E, 20F of the sizing templates. The sizing templateshave second sides or segments 56A, 56B, 56C, 56D, 56E, 56F adjacent tothe first sides or segments 54A, 54B, 54C, 54D, 54E, 54F . Third sidesor segments 58A, 58B, 58C, 58D, 58E, 58F are at the distal ends 21A,21B, 21C, 21D, 21E, 21F of the sizing templates. In each sizingtemplate, the second side or segment 56A, 56B, 56C, 56D, 56E, 56F isbetween the first side or segment 54A, 54B, 54C, 54D, 54E, 54F and thirdside or segment 58A, 58B, 58C, 58D, 58E, 58F.

Although each of the illustrated sizing templates 16A-16F has threesides or segments 54A-54F, 56A-56F and 58A-58F, it should be understoodthat fewer or additional segments in different shapes could be used. Theinvention is not limited to any particular number or shape of the distalend of the sizing template unless expressly called for in the claims.

In addition, in the instrument set 10 of FIGS. 1 and 2, the three sidesor segments 54A-54F, 56A-56F, 58A-58F are all resilient. However, asdescribed below with respect to FIGS. 29 and 30, the sides or segmentscomprising the template need not be resilient, and the present inventionis not limited to resilient templates unless expressly called for in theclaims.

As illustrated in FIGS. 9, 11 and 13, the intermediate portion 20A, 20B,20C, 20D, 20E, 20F of each sizing template 16A, 16B, 16C, 16D, 16E, 16Fhas a central longitudinal axis 60A, 60B, 60C, 60D, 60E, 60F. The firstsegment 54A, 54B, 54C, 54D, 54E, 54F of each sizing template has alongitudinal axis 62A, 62B, 62C, 62D, 62E, 62F defining an angle a withthe central longitudinal axis 60A, 60B, 60C, 60D, 60E, 60F of theintermediate portion 20A, 20B, 20C, 20D, 20E, 20F. In the illustratedembodiments, the angle a is 1200 when the sizing template 16A, 16B, 16C,16D, 16E, 16F is in its extended position, although it should beunderstood that the invention is not limited to any particular angleunless expressly set forth in the claims. The second segment 56A, 56B,56C, 56D, 56E, 56F in each of the illustrated embodiments is curved,having a radius of 1.47 inches, although it should be understood thatthe invention is not limited to any particular radius or to a curvedshape unless expressly set forth in the claims. The third segment 58A,58B, 58C, 58D, 58E, 58F in each illustrated sizing template issubstantially parallel to the first segment 54A, 54B, 54C, 54D, 54E, 54Fwhen in the extended position, and has a blunt distal end. Each of theillustrated sizing templates 16A, 16B, 16C, 16D, 16E, 16F comprises anelongated wire having an outer diameter of 0.03 inches along its entirelength, although it should be understood that the invention is notlimited to any particular diameter of sizing template unless expresslyset forth in the claims. For each of the three illustrated sizingtemplates, the three distal segments 54A-54F, 56A-56F, 58A-58F define anoverall U-shape in plan view, although the invention is not limited tosuch a shape unless expressly called for in the claims.

Each of the illustrated large sizing templates 16A, 16D has a dimensionD₁ between the first segment 54A, 54D and the third segment 58A, 58D of0.98 inches and a dimension D₂ corresponding with the lengths of thefirst segment 54A, 54D and third segment 58A, 58D of 0.47 inches. Eachof the illustrated medium sizing templates 16B, 16E has a dimension D₃between the first segments 54B, 54E and the third segment 58B, 58E of0.79 inches and a dimension D₄ corresponding with the lengths of thefirst segment 54B, 54E and third segment 58B, 58E of 0.47 inches. Eachof the illustrated small sizing templates 16C, 16F have a dimension D₅between the first segment 54C, 54F and the third segment 58C, 58F of0.59 inches and a dimension D₆ corresponding with the lengths of thefirst segment 54C, 54F and third segment 58C, 58F of 0.47 inches. Itshould be understood that all of these dimensions are provided asexamples only; the present invention is not limited to any particulardimension unless expressly called for in the claims.

In each of the illustrated embodiments, the three segments 54A-54F,56A-56F, 58A-58F of each sizing template 16A-16F are co-planar with therespective intermediate portion 20A-20F. However, it should beunderstood that the segments could be angled to lie in a separate plane.In addition, the one or more of the segments could lie in a planeseparate from that of the other segments.

Thus, for the large sizing template 16A, 16D, the distance D₁corresponds with the length L₃ of the wedge 57 of the large size implant50 and the distance D₂ corresponds with the width W₃ of the wedge 57 ofthe large size implant 50. For the medium sizing template 16B, 16E, thedistance D₃ corresponds with the length L₄ of the wedge 57 of the mediumsize implant 52 and the distance D₄ corresponds with the width W₄ of thewedge 57 of the medium size implant 52. For the small sizing template16C, 16F, the distance D₅ corresponds with the length L₆ of the wedge 57of the small size implant 53 and the distance D₆ corresponds with thewidth W₆ of the wedge 57 of the small size implant 53. It should beunderstood that these correspondences in dimensions between the wedgesof the implants and the sizing templates are provided as examples only;the sizing templates could instead be set to correspond for example withthe outer dimensions of the covers 55 of the implants, or with someother feature of the implant as well. Accordingly, the present inventionshould not be limited to any particular correspondence of template sizeand implant size unless expressly set forth in the claims.

For each of the illustrated sizing templates, all three segments54A-54F, 56A-56F, and 58A-58F are exposed outside of the distal ends18A-18F of the respective tubes 14A-14F when the sizing template 16A-16Fis in the extended position. All three segments 54A-54F, 56A-56F and58A-58F are held within the channels 30A-30F of the respective tubes14A-14F when the sizing template 16A-16F is in the retracted position.

FIG. 19 illustrates the large sizing template 16A in the retractedposition within the straight tube 14A; FIG. 20 illustrates the mediumsizing template 16B in the retracted position within the straight tube14B; and FIG. 21 illustrates the small sizing template 16C in theretracted position within the straight tube 14C. FIG. 22 illustrates thelarge sizing template 16D in the retracted position within the angledtube 14D; FIG. 23 illustrates the medium sizing template 16E in theretracted position within the angled tube 14E; and FIG. 24 illustratesthe small sizing template 16F in the retracted position within theangled tube 14F.

To allow the sizing templates 16A, 16B, 16C, 16D, 16E, 16F to berepeatedly retracted and extended, and to regain the desired shape inthe extended position, the sizing templates may be made of asuper-elastic or shape-memory material. The template material should beone that can be shaped into a pre-determined shape (such as the shapesillustrated in FIGS. 9, 11, 13 and 16-18), have sufficient rigidity toretain its pre-determined shape when extended over a distance such as10-50 mm, that can deform to fit within the shape of the channel 30A-30Fof the tube 14A-14F when retracted, and that will regain itspre-determined shape when extended beyond the channel. Finally, thematerial should be one that is suitable for surgical use. An example ofa suitable material is nitinol (nickel-titanium alloy). It isanticipated that other alloys and other materials such as polymers andcomposites will also be usable as a shape memory material for therulers. Accordingly, the present invention should not be limited to anyparticular material unless expressly called for in the claims.

To ease movement of the sizing templates 16A, 16B, 16C, 16D, 16E, 16Fextended and retracted positions, the handle assembly 26A-26F of theillustrated instrument set 10 utilizes a gear mechanism that the surgeoncan manipulate with the thumb or finger of the same hand that is used tograsp the handle assembly 26A-26F. The handle assembly 26A-26F in eachof the illustrated instruments is the same.

A representative handle assembly is shown in longitudinal cross-sectionin FIG. 25 and in transverse cross-section in FIG. 26. In FIGS. 25 and26 and in the following description of the handle assemblies, referencenumbers are used without letter designations to indicate that theillustration and description applies to the handle assemblies 26A, 26B,26C, 26D, 26E, 26F of all the illustrated instruments 12A, 12B, 12C,12D, 12E, 12F.

As shown in FIG. 25, the handle assembly 26 includes a base 64, a handlepost 66, two screws 68, 70, a thumb gear assembly 72, a spur gear 74 andtwo ball plungers 76. The base 64 has a distal longitudinal channel 78and two transverse bores in communication with the distal longitudinalchannel. The distal longitudinal channel 78 receives the shoulder 34 ofthe tube assembly, and the two ball plungers 76 are inserted into thebores to engage the dimples 40 in the shoulder 34 to thereby mount thetube assembly to the handle assembly 26. The distal longitudinal channel78 communicates with a longitudinal distal bore 80, which communicateswith a central open area 82, which communicates with a longitudinalfemale threaded opening 84. The female threaded opening 84 receives adistal male threaded portion 86 of the post 66. The post 66 includes alongitudinal channel 88 that communicates with the central open area 82and extends to or near the proximal end 90 of the post 66. The distallongitudinal channel 78 and longitudinal distal bore 80 of the base 64and longitudinal channel 88 of the post 66 are co-axial with the channel30 of the tube 14. The sizing template 16 extends through the tube 14,through the distal channel 36 of the shoulder 34, through the reduceddiameter proximal channel 38 of the shoulder 34, through thelongitudinal distal bore 80 of the base 64, through the central openarea 82 of the base and through the longitudinal channel 88 of the post66. In the central open area 82 of the base 64, the sizing template 16passes between the thumb gear assembly 72 and the spur gear 74.

As shown in FIGS. 25 and 26, the thumb gear assembly 72 is mounted tothe base 64 by the screw 68 and the spur gear 74 is mounted to the base64 by the screw 70. The thumb gear assembly 72 is freely rotatable onthe smooth shaft of the screw 68 and the spur gear 74 is freelyrotatable on the smooth shaft of the screw 70.

The thumb screw assembly 72 comprises a thumb wheel 90 and a thumb gear92 mounted coaxially on the screw 68. The outer surface of the thumbwheel 90 has a plurality of axial splines 94 so that the surgeon caneasily rotate the wheel 90 with a thumb or finger. The thumb wheel 90receives a reduced diameter portion of the thumb gear 92 so that thethumb wheel 90 and thumb gear 92 rotate together.

The thumb gear 92 has a plurality of grooved teeth 94 that intermeshwith the grooved teeth 96 of the spur gear 74. As shown in FIG. 26, theintermeshing grooved teeth 94 of the thumb gear 92 and grooved teeth 96of the spur gear 74 define a passageway 98 that is co-axially alignedwith the distal longitudinal channel 78 and longitudinal distal bore 80of the base 64 and longitudinal channel 88 of the post 66. Theintermediate portion 20 of the sizing template 16 extends between thethumb gear 92 and the spur gear 74, passing through the passageway 98defined by the grooved teeth 94, 96. Where the proximal surface of oneof the thumb gear teeth 94 meets and engages the distal surface of oneof the spur gear teeth 96, at least one of the transverse dimensions ofthe passageway 98 is slightly less than the outer diameter of theintermediate portion 20 of the sizing template 16 so that the matingteeth 94, 96 grip the sizing template 16. Thus, the sizing template 16can be reciprocated in the proximal-distal direction by rotating thethumb wheel 90, and the surgeon can extend and retract the sizingtemplate 16 with the same hand used to grasp the handle post 66.

All of the components of the handle assembly 26 can be made of standardmaterials for surgical instruments. For example, the base 64 and post 66can be made of acetyl co-polymer, and the gears 74, 92, thumb wheel 90,screws 68, 70 and ball plungers 76 can be made of stainless steel. Itshould be understood that all of these materials are identified asexamples only; the present invention is not limited to any particularmaterial unless expressly called for in the claims.

Use of the illustrated instrument set 10 is described below andillustrated in FIG. 28 in treating a defect 100 in the meniscus 102. Inthe illustrations, the tissue defect 100 comprises a gap in theposterior portion of the medial horn 104 of the meniscus 102 created bya partial menisectomy. Although not described in detail below, it shouldbe understood that the technique described below may also be used intreating tissue defects in other areas of the medial horn 104 of themeniscus as well as in the lateral horn 106 of the meniscus. It shouldalso be understood that the technique described below may also beapplied in treating defects at other tissue sites in a patient's body.In FIG. 28, a portion of the anterior cruciate ligament is shown at 108and a portion of the posterior cruciate ligament is shown at 110.

The surgeon can perform standard arthroscopic procedures to createportals to gain access to the medial horn 104 of the meniscus. Standardcannulae can be inserted through the portals, and a standard arthroscope(not shown) can be used for visualization of the tissue site. Anappropriate sizing instrument, for example the medium instrument with a45° offset is selected. It should be understood that the selection ofthe shape of the sizing instrument will depend on the defect site,surgical approach and surgeon preference. The 45° offset instrument isdiscussed below as an example only.

In the case illustrated in FIG. 28, because of the defect site andsurgical approach, the 45° offset sizing instrument has been flipped1800 from the position illustrated in FIG. 1 so that the bottom side ofthe instrument is facing up and so that the distal end 18E of the tube14E is angled to the left. The surgeon selects the size of the sizinginstrument based upon an initial approximation of the size of implant tobe used to repair the defect.

The surgeon may then retract the three segments 54E, 56E, 58E into thechannel 30 of the tube so that the sizing template 16E is in theretracted position shown in FIGS. 2 and 23. The tube 14E may then beinserted through one of the cannulae and guided to the medial meniscus104.

When the distal end 18E of the tube 14E is in position at the medialmeniscus 104, the surgeon may extend the sizing template by turning thethumb wheel 90 with a finger on the same hand that is used to hold thepost 66 of the instrument. When the sizing template 16E has been fullyextended to the positions shown in FIGS. 1 and 11, the surgeon can thenmove the sizing template 16E until the shaped segments 54E, 56E, 58Eoverlie or fit within the edges of the tissue defect 100. As illustratedin FIG. 28, the defect 100 is visible (either be means of thearthroscope or by eye if the instruments are used in open surgery) evenwith the shaped end of the sizing template 16E in place over or withinthe defect. If the surgeon is satisfied that an implant correspondingwith the size of the template will be appropriate for the defect, thesurgeon can then turn the thumb wheel 90 to retract the sizing template16E and remove the instrument 12E. An implant may then be delivered andfixed implant in place. If the surgeon is not satisfied that the implantcorresponding with that sizing template is appropriate, the surgeon canretract the sizing template, remove the instrument 12E and then followthe same procedure with the larger sizing instrument 12D or smallersizing instrument 12F until satisfied that the most appropriate size ofimplant will be used.

Using the instrument set 10 with retractable and extendable sizingtemplates, the surgeon can use templates having shapes and sizes thatwould not normally fit through an arthroscopic cannula, and that couldbe damaged or become misshapen if introduced without a cannula.

To deliver the implant arthroscopically, devices may be used like thosedisclosed in the following U.S. patent applications, which areincorporated by reference herein in their entireties: U.S. patentapplication Ser. No. 10/610,287 entitled “Slide and Kit for DeliveringImplants” (filed Jun. 30, 2003) and U.S. Provisional Patent ApplicationSer. No. 60/483,804 entitled “Instrument for Delivery of Implant” (filedJun. 30, 2003). However, the present invention is not limited to anyparticular implant, surgical technique or surgical instrument unlessexpressly set forth in the claims.

Although the technique of the present invention has been described abovewith respect to an arthroscopic procedure, it should be understood thatthe instruments and technique of the present invention can also be usedwith more invasive surgical procedures, such as a mini-arthrotomy or anopen surgical procedure.

While the illustrated instrument set 10 all utilize retractable sizingtemplates 16, it should be understood that some of the advantages of thepresent invention can also be obtained through use of instruments havinga non-retractable sizing template. Examples of such instruments areillustrated in FIGS. 29-30. While the instruments of FIGS. 29-30 may notbe as easily introduced to the defect site, they do offer advantages.The instrument 110 of FIG. 29 allows the surgeon to view therelationship between the size of the defect and the size of the template112 without the template covering the defect, and both the instruments110, 114 of FIGS. 29 and 30 offer the opportunity to determine theappropriate size of implant that best suits the size of the defect. Thetemplate portion 112, 116 of the instruments of FIGS. 29-30 can be madeor stainless steel, a polymer or a composite, and can be designed to bereusable or disposable after each use, while the handle could also bedesigned to be reusable or disposable. The template portions 112, 116 ofthe instruments illustrated in FIGS. 29-30 have sides 118, 120, 122,124, 126, 128 that correspond in length and orientation with sides oredges of the soft tissue implants. It should be understood thatinstrument sets utilizing the designs of FIGS. 29 and 30 would includeseveral instruments with different sizes of distal ends, and wouldinclude instruments corresponding with the different sizes of implantsavailable.

It should be appreciated that some of the features of the retractableinstrument set 10 can also be applied to other types of surgicalinstruments. For example, a thumb gear assembly and spur gear on aninstrument handle to extend and retract another component of theinstrument can be applied to other surgical instruments, particularlythose in which the component to be extended and retracted comprises ashape-memory material such as nitinol. One example of such a possibleuse of the intermeshing gears is in the United States Provisional PatentApplication filed concurrently herewith by Anthony D. Zannis, Jack Farr,M.D., Randall L. Holcomb, M.D., Herbert E. Schwartz, Prasanna Malaviya,Keith M. McGrath, Danny E. McAdams and Andrew M. Jacobs and entitled“Coordinate Instrument Set”, the complete disclosure of which isincorporated by reference herein.

While only specific embodiments of the invention have been described andshown, it is apparent that various alternatives and modifications can bemade thereto. Those skilled in the art will also recognize that certainadditions can be made to the illustrative embodiments. It is, therefore,the intention in the appended claims to cover all such alternatives,modifications and additions as may fall within the true scope of theinvention.

1. A method of repairing soft tissue comprising: removing soft tissue tocreate a defect having a first side having a length and orientation anda second non-parallel side having a length and orientation; providing afirst implant including a first side having a length and orientation anda second non-parallel side having a length and orientation; providing asecond implant including a first side having a length and orientationand a second non-parallel side having a length and orientation;providing a first sizing template including a first side having a lengthand orientation corresponding to the length and orientation of the firstside of the first implant and a second side having a length andorientation corresponding to the length and orientation of the secondside of the first implant; providing a second sizing template includinga first side having a length and orientation corresponding to the lengthand orientation of the first side of the second implant and a secondside having a length and orientation corresponding to the length andorientation of the second side of the second implant; introducing one ofthe sizing templates to the area of the defect and positioning thesizing template with its first side at the first side of the defect andwith its second side at the second side of the defect; determiningwhether the introduced sizing template fits the defect; removing thesizing template; introducing one of the implants to the area of thedefect and positioning the implant in the defect.
 2. The method of claim1 wherein the soft tissue comprises the meniscus.
 3. The method of claim1 wherein at least the majority of the defect is visible with the sizingtemplate in position at the defect.
 4. The method of claim 1 wherein thestep of introducing the sizing template to the area of the defect andthe step of introducing one of the implants to the area of the defectare done arthroscopically.
 5. The method of claim 1 wherein the sizingtemplate is introduced through a cannula.
 6. The method of claim 1wherein the step of removing tissue comprises performing a partialmeniscectomy.
 7. The method of claim 1 wherein the second side of thefirst sizing template and second side of the second sizing template arecurved.
 8. The method of claim 1 wherein: the first sizing templateincludes a third side connected to the second side, and the second sideis connected to the first side; the second sizing template includes athird side connected to the second side, and the second side isconnected to the first side.
 9. The method of claim 8 wherein the firstside, second side and third side of the first sizing template comprisesegments of a wire and the first side, second side and third side of thesecond sizing template comprise segments of a wire.